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WO2005046488A2 - Systeme de reduction de l'annulus des valvules cardiaques - Google Patents

Systeme de reduction de l'annulus des valvules cardiaques Download PDF

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Publication number
WO2005046488A2
WO2005046488A2 PCT/US2004/037867 US2004037867W WO2005046488A2 WO 2005046488 A2 WO2005046488 A2 WO 2005046488A2 US 2004037867 W US2004037867 W US 2004037867W WO 2005046488 A2 WO2005046488 A2 WO 2005046488A2
Authority
WO
WIPO (PCT)
Prior art keywords
filament
annulus
reduction
ring
barbs
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2004/037867
Other languages
English (en)
Other versions
WO2005046488A3 (fr
Inventor
Nareak Douk
Nasser Rafiee
Eliot Bloom
Douglas A. Fogg
Rany Huynh
David D. Barone
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Vascular Inc
Original Assignee
Medtronic Vascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Vascular Inc filed Critical Medtronic Vascular Inc
Priority to JP2006539913A priority Critical patent/JP2007510525A/ja
Priority to EP04810885A priority patent/EP1689329A2/fr
Priority to US10/531,819 priority patent/US7655040B2/en
Publication of WO2005046488A2 publication Critical patent/WO2005046488A2/fr
Publication of WO2005046488A3 publication Critical patent/WO2005046488A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30545—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting a diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter

Definitions

  • the technical field of this disclosure is medical devices, particularly, a cardiac valve annulus reduction system and method of using the same.
  • Heart valves such as the mitral valve, tricuspid, aortic and pulmonic valves, are sometimes damaged by disease or by aging, which can cause problems with the proper function of the valve.
  • Heart valve problems generally take one of two forms: stenosis, in which a valve does not open completely or the opening is too small, resulting in restricted blood flow; or insufficiency, in which blood leaks backward across the valve that should be closed.
  • Valve replacement may be required in severe cases to restore cardiac function.
  • repair or replacement requires open- heart surgery with its attendant risks, expense, and extended recovery time. Open-heart surgery also requires cardiopulmonary bypass with risk of thrombosis, stroke, and infarction.
  • mitral valve insufficiency may result. Any one or more of the mitral valve structures, i.e., the anterior and posterior leaflets, the chordae, the papillary muscles or the annulus may be compromised by damage from disease or injury, causing the mitral valve insufficiency. Typically, in cases where there is mitral valve insufficiency, there is some degree of annular dilation resulting in mitral valve regurgitation. Mitral valve regurgitation occurs as the result of the leaflets being moved back from each other by the dilated annulus, thus making the leaflets unable to appose each other completely during systole.
  • mitral valve insufficiency may lead to disease progression and/or further enlargement and worsening of the insufficiency.
  • correction of the regurgitation may not require repair of the valve leaflets themselves, but simply a reduction in the size of the annulus.
  • a variety of techniques have been attempted to reduce the diameter of the mitral annulus and eliminate or reduce valvular regurgitation in patients with incompetent valves.
  • Current surgery to correct mitral regurgitation in humans includes a number of mitral valve replacement and repair techniques.
  • Valve replacement can be performed through open-heart surgery, open chest surgery, or percutaneously. The native valve is removed and replaced with a prosthetic valve, or a prosthetic valve is placed over the native valve.
  • the valve replacement may be a mechanical or biological valve prosthesis.
  • the open chest and percutaneous procedures avoid opening the heart and cardiopulmonary bypass.
  • the valve replacement may result in a number of complications including a risk of endocarditis.
  • mechanical valve replacement requires subsequent anticoagulation treatment to prevent thromboembolisms.
  • valve repair techniques including quadrangular segmental resection of a diseased posterior leaflet; transposition of posterior leaflet chordae to the anterior leaflet; valvuloplasty with plication and direct suturing of the native valve; substitution, reattachment or shortening of chordae tendinae; and annuloplasty in which the effective size of the valve annulus is contracted by attaching a prosthetic annuloplasty ring to the endocardial surface of the heart around the valve annulus.
  • the annuloplasty techniques may be used in conjunction with other repair techniques. Typically such rings are sutured along the posterior mitral leaflet adjacent to the mitral annulus in the left atrium.
  • the rings either partially or completely encircle the valve, and may be rigid or flexible/non-elastic. All of these procedures require cardiopulmonary bypass, though some less and minimally invasive techniques for valve repair and replacement are being developed. [0007] Although mitral valve repair and replacement can successfully treat many patients with mitral valve insufficiency, techniques currently in use are attended by significant morbity and mortality. Most valve repair and replacement procedures require a thoractomy to gain access into the patient's thoracic cavity. Surgical intervention within the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system and arrest of cardiac function. Open chest techniques with large sternum openings are typically used.
  • a prosthesis is transvenously advanced into the coronary sinus and deployed within the coronary sinus to reduce the diameter of the mitral valve annulus.
  • the prosthesis is tightened down within the coronary sinus to reduce the mitral valve annulus. This may be accomplished in an open surgical procedure or by percutaneous transluminal access through the venous system by one of the internal jugular, subclavian or femoral veins.
  • the coronary sinus implant provides a less invasive treatment alternative
  • the placement of the prosthesis within the coronary sinus may be problematic for a number of reasons.
  • the coronary sinus is not accessible.
  • the coronary sinus on a particular individual may not wrap around the heart far enough to allow enough encircling of the mitral valve.
  • leaving a device in the coronary sinus may result in formation and release of thrombus that may pass into the right atrium, right ventricle and ultimately into the lungs, possibly causing a pulmonary embolism.
  • Another disadvantage is that the coronary sinus is typically used for placement of a pacing lead, which may be precluded by the previous placement of a prosthesis in the coronary sinus. [00010] It would be desirable, therefore, to provide a method and device for reducing cardiac valve regurgitation that would overcome these and other disadvantages.
  • One aspect of the present invention provides a cardiac valve annulus reduction system to provide catheter based valve repair.
  • the system for treating mitral valve regurgitation comprises a catheter, a tubular member carried within the catheter, the tubular member including a plurality of openings formed in a sidewall of the tubular member and an barb assembly received in the tubular member.
  • the barb assembly includes a plurality of radially extendible barbs corresponding to the sidewall openings.
  • the tubular member carrying the barb assembly is deployed adjacent a mitral valve annulus and the barb assembly is translated relative to the tubular member to deploy the barbs through the sidewall openings and into the annulus and to further translate the tubular member with deployed barbs to reshape the annulus.
  • Another aspect of the invention provides a method for treating mitral valve regurgitation.
  • the method comprises deploying a tubular member carrying an barb assembly adjacent a mitral valve annulus via a catheter, translating the barb assembly relative to the tubular member, inserting barb portions of the barb assembly through tubular member sidewall openings and into the annulus responsive to the translation and translating the inserted barbs and tubular member with the barb assembly to reshape the annulus.
  • Another aspect of the invention provides a system for treating mitral valve regurgitation.
  • the system comprises means for reducing a mitral valve annulus, means for translating a barb assembly relative to a tubular member, means for inserting barb portions of the barb assembly through tubular member sidewall openings and into the annulus responsive to the translation and means for locking the barb assembly relative to the tubular member.
  • FIG. 1 shows a cardiac valve annulus reduction delivery system in accordance with the present invention
  • FIG. 2 shows a cardiac valve annulus reduction delivery system positioned within the left atrium in accordance with the present invention
  • FIG. 3 shows a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIGS. 4-5 show another embodiment of a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIGS. 6-7 show detailed views of a reduction ring and barb assembly for a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIGS. 8-10 show detailed views of another reduction ring and barb assembly for a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIG.21 shows a cardiac valve annulus reduction delivery system in accordance with the present invention
  • FIG. 11 shows detailed views of another reduction ring and barb assembly for a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIGS. 12-13 show detailed views of a lock mechanism for a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIGS. 14-16 show detailed views of another lock mechanism for a cardiac valve annulus reduction assembly in accordance with the present invention
  • FIG. 17 shows one embodiment of a delivery system for a cardiac valve annulus reduction assembly in accordance with the present invention positioned within the heart
  • FIG. 18 shows one embodiment of a wireform, shown in a delivery configuration for use in the delivery system of FIG. 17
  • FIG. 19 shows one embodiment of a delivery catheter for delivering the wireform of FIG.
  • FIG. 20 shows one embodiment of a delivery catheter for delivering a cardiac valve annulus reduction assembly using the delivery system of FIG. 17 in accordance with the present invention
  • FIG. 21 shows another embodiment of a delivery catheter for delivering a cardiac valve annulus reduction assembly using the delivery system of FIG. 17 in accordance with the present invention
  • FIG. 22 shows another embodiment of a wireform in a delivery configuration for use in the delivery system of FIG. 17
  • FIG. 23 shows a flow chart for a method of implanting a cardiac valve annulus reduction assembly in accordance with the present invention.
  • FIG. 1 shows a cardiac valve annulus reduction assembly and a delivery system in accordance with the present invention.
  • Annulus reduction delivery system 100 includes delivery catheter 110 having lumen 114 there through.
  • Annulus reduction assembly 120 is disposed within lumen 114 and is described in more detail below.
  • FIG. 2 shows a delivery system 100 positioned via a femoral venous transeptal approach with the system distal end lying within the left atrium. As shown, annulus reduction assembly 120 has not been deployed from delivery catheter 110. Annulus reduction assembly 120 may be delivered via percutaneous transluminal techniques or via surgery using open-chest or port access modalities.
  • annulus reduction assembly 120 is implanted from the left atrium 130.
  • An elongate element 132 such as a catheter having lumen 134, is first inserted to provide a path for annulus reduction delivery system 100 from the exterior of the patient to left atrium 130.
  • Annulus reduction delivery system 100 can then be advanced through lumen 134 so that annulus reduction assembly 120 is located at mitral valve annulus 136 for deployment.
  • FIG. 2 illustrates a transeptal approach through the vena cava.
  • elongate element 132 is inserted into the femoral vein and passed through the common iliac vein, inferior vena cava 138 and into right atrium 140.
  • Atrial septum 142 is punctured with a guide wire or other puncturing device, and the distal end of elongate element 132 is advanced into left atrium 130.
  • Annulus reduction assembly 120 may then be advanced through lumen 134 of elongate element 132 to the mitral valve for implantation.
  • elongate element 132 is a puncture catheter, as are well known in the art, configured to pierce the atrial septal wall.
  • the delivery method may also include a dilator catheter for providing a larger diameter pathway for delivering annulus reduction delivery system 100.
  • distal and proximal are used herein with reference to the treating clinician during deployment of the device; “Distal” indicates a portion distant from, or a direction away from the clinician and “proximal” indicates a portion near to, or a direction towards the clinician.
  • distal indicates a portion distant from, or a direction away from the clinician
  • proximal indicates a portion near to, or a direction towards the clinician.
  • the elongate element can be a trocar or cannula inserted directly in the vena cava or the aortic arch. Elongate element 132 can then follow the same path as the percutaneous transluminal procedure to reach the left atrium, either transeptally or through the cardiac valves.
  • FIG. 3 shows one embodiment of an annulus reduction assembly 200 in accordance with the present invention.
  • Annulus reduction assembly 200 includes barb assembly 210, reduction ring 220, locking assembly 230 and reshaping cord 240.
  • FIG. 3 also illustrates annulus reduction delivery system 250, which will be described in detail below.
  • Reduction ring 220 comprises a tubular member 226 having through lumen 227.
  • Reduction ring 220 includes a plurality of barb exit ports 224 and temporary barb 222.
  • Reduction ring 220 is composed of a flexible, biocompatible implant material including a metallic base or a polymeric base, such as stainless steel, nitinol, platinum alloy, titanium, chromium-based alloy, cobalt-based alloy, thermoplastic or thermoset polymer, or a combination thereof.
  • Exit port 224 may be any shape and size to allow the passage of barb penetrating member 218.
  • exit port 224 is oval.
  • Exit ports 224 are positioned on reduction ring 220 such that, when annulus reduction assembly 200 is deployed, exit ports 224 are adjacent the valve annulus.
  • the plurality of exit ports 224 may be linearly aligned along one side of reduction ring 220 such that, when annulus reduction assembly 200 is formed into a general ring shape adjacent the valve annulus, exit ports 224 may be arranged along the outer diameter or perimeter of the ring, in the plane of the ring.
  • exit ports 224 may be arranged adjacent the outer diameter or perimeter of the ring, with ports 224 being oriented at least slightly towards the valve leaflets at an acute angle from the plane of the ring.
  • Reduction ring 220 further includes temporary barb 222 positioned at reduction ring distal end 223. Temporary barb 222 may be used to provide stability during the first stages of the implantation procedure, as by temporarily holding reduction ring 220 at the implantation site before insertion of barb penetrating members 218 into the valve annulus.
  • Reduction ring 220 may also include a plurality of anchors 225 disposed along and protruding from reduction ring outer surface 228. Anchors 225 provide additional anchoring of the implanted ring to the valve annulus and are linearly positioned on outer surface 228 that will be adjacent the valve annulus.
  • Barb assembly 210 is movably disposed within lumen
  • Barb assembly 210 includes filament 214 and a plurality of radially self-extending barbs 212 securely attached to filament 214.
  • Filament 214 can be made of any biocompatible metal or polymer that can be formed into a ring shape when deployed at the cardiac valve annulus.
  • filament 214 is a braided polyester cord.
  • filament 214 is stainless steel or another metallic wire.
  • Each barb 212 is positioned adjacent a corresponding exit port 224 of tubular member 226.
  • Barbs 212 comprise a barb body 216 and a radially self- extending, tissue-penetrating portion 218.
  • Tubular member 226 restrains barbs 212 until barb assembly 210 is translated within tubular member 226 to allow tissue-penetrating portions 218 to extend through exit ports 224.
  • Barbs 212 may be fixedly attached to filament 214 via barb body 216 using a crimp, an adhesive or any other method of attachment well known in the art.
  • barbs 214 and filament 214 are fashioned from the same piece of material.
  • penetrating portion 218 is composed of shape memory material such as nitinol. Alternatively, penetrating portion 218 may comprise another metal such as stainless steel, cobalt-based alloy or combinations thereof. The number and position of barbs 212 and corresponding exit ports 224 may vary depending on the intended result.
  • Locking assembly 230 includes a plurality of key members 232 and lock 234 that function similarly to a ratchet and pawl mechanism. Key members 232 and lock 234 are disposed at opposite ends of filament 214. Key members 232 are serially attached along filament distal end 260 and lock 234 is attached to filament proximal end 262. FIGS. 12-13 illustrate locking assembly 230 in greater detail. [00041] Referring to FIGS. 12-13, each key member 232 comprises key body 236 having deflectable tab 238. Key bodies 236 are disposed on filament 214 in a spaced apart manner using a crimp, an adhesive or any other method of attachment known in the art. Key bodies 236 may be composed of biocompatible metal, polymer or combinations thereof.
  • Tab 238 normally forms an acute angle with filament 214 and is elastically deformable towards filament 214 to allow movement of key member 232 through lock 234 in only one direction. Movement of key member 232 through lock 234 in the opposite direction is prevented by the resistance of tab 238 to deformation away from filament 214. Such reverse movement, or unlocking, is also prevented because tab 238 would have to fold over key body 236, creating a combined transverse dimension that will not fit through lock lumen 235.
  • Deflectable tab 238 may be composed of biocompatible metal, polymer or combinations thereof. Deflectable tab 238 may be integrally formed with, or attached to key body 236 by welding, crimping, adhesive, or any other method known to those with skill in the art.
  • locking assembly 230 may also include a plurality of stops 237.
  • a stop 237 is positioned on either side of key body 236 and securely attached to filament 214 to prevent movement of key member 232 along filament 214.
  • Lock 234 may be composed of biocompatible metal, polymer or combinations thereof.
  • FIGS. 12 and 13 illustrate movement of a first key member 232 through lumen 235 of lock 234. As filament 214 is pulled in the direction of arrow A, first key member 239 passes through lock lumen 235. As first key member 239 passes through lumen 235, deflectable tab 238A deflects in the direction of arrow B.
  • annulus reduction assembly 200 includes reshaping cord 240 looped through cord ring 242 disposed at filament distal end 260. Both ends (not shown) of reshaping cord 240 are further threaded through lock lumen 235.
  • reshaping cord 240 comprises a string or cord-like material having sufficient length such that both ends extend through annulus reduction delivery system 250 and out of the patient for manipulation by the clinician.
  • FIG. 3 further illustrates annulus reduction delivery system 250.
  • Annulus reduction delivery system 250 includes a plurality of coaxially arranged tubular components, as follows. Delivery catheter 252 has lumen 253; Ring holding tube 254 has lumen 255 and is disposed within lumen 253: Lock holding tube 256 has lumen 257 and is disposed within lumen 255.
  • Annulus reduction delivery system 250 further includes actuator cord 258, which is similar to reshaping cord 240. Actuator cord 240 is releasably connected to lock 234.
  • FIGS. 4-5 illustrate another embodiment of a cardiac valve annulus reduction system in accordance with the present invention.
  • FIG. 4 shows a detailed view of annulus reduction assembly 415.
  • Annulus reduction assembly 415 includes reduction ring 420, filament 430, locking assembly 450 and reshaping cord 460.
  • Reduction ring 420 includes a plurality of exit ports 425 and lumen 422. Filament 430 is disposed within lumen 422 of reduction ring 420.
  • Filament 430 includes a plurality of barbs 435 positioned adjacent exit ports 425. Barbs 435 may be composed of materials such as nitinol, cobalt based alloy, stainless steel, or combinations thereof. Filament 430 also includes proximal end 432 and distal end 434. Proximal end 432 is secured to lock 470, as best seen in FIG. 4. [00047] Locking assembly 450 is attached to filament distal end
  • Key member 452 also includes deflectable tab 456.
  • Deflectable tabs 456 are similar to deflectable tabs 238 of FIGS 12-13 described above.
  • Reshaping cord 460 is attached to filament distal end
  • Annulus reduction assembly 415 further includes holding tube 480 positioned proximal to lock 470. Holding tube 480 includes lumen 482 through which reshaping cord 460 passes.
  • holding tube 480 holds lock 470 in place, keeping it from moving in a proximal direction while annulus reduction assembly 415 is formed into a ring shape: [00050]
  • annulus reduction assembly 415 is delivered to the cardiac valve in a manner as described above in FIG. 2.
  • Annulus reduction assembly 415 is delivered in a straightened delivery configuration.
  • the physician begins the implantation by pulling reshaping cord 460 in a proximal direction while at the same time keeping filament proximal end 432 stationary via holding tube 480 to form the general ring structure of the annulus reduction ring 420.
  • the mitral valve is not perfectly circular; the anterior portion of the mitral valve annulus is relatively straight such that the mitral valve annulus approximates a "D" shape.
  • Annulus reduction assembly 415 may be preformed to resemble the "D" shape of the mitral valve.
  • Exit ports 425 may be arranged along the outermost perimeter of ring 420, in the plane of the ring 420.
  • exit ports 425 may be arranged adjacent the outer diameter or perimeter of the ring, with ports 224 being oriented at an acute angle directed below the plane of the ring, towards the valve leaflets. Exit ports 425 may be spaced non-uniformly around the perimeter of reduction ring 420, as shown in FIGS. 4 and 5, such that barbs 435 extending from exit ports 425 and into the valve annulus can apply annulus reduction forces to selected locations around the valve annulus. [00052] It may be noted that, in annulus reduction assembly 415, barbs 435 are oriented in a direction opposite to the direction of barbs 212 in the above embodiment of annulus reduction assembly 200.
  • valve annulus reduction assembly 415 remains locked in the desired configuration.
  • the annulus reduction assembly 415 is locked during translation of locking assembly 450 through lock 470 as the reduction ring and valve annulus are formed to the desired shape and size. Additional translation of filament 430 is not required to lock the annulus reduction assembly 415.
  • the locking mechanism is actuated by the movement of at least one key member 452 through lock 470. As key member 452 passes through lock 470, deflectable tab 456 deflects sufficiently towards filament 430 to pass through lock lumen 472.
  • FIGS. 6 and 7 illustrate another embodiment of a barb assembly 610 and reduction ring 620 for annulus reduction assembly 600.
  • Barb assembly 610 may be fabricated from thin wall tubing and is sized to fit slidably within lumen 630 of reduction ring 620.
  • Barb assembly 610 includes a plurality of barbs 614 that are integrally formed from, or fixedly attached to outer surface 615.
  • Barb assembly 610 also includes lock members 616 that are integrally formed from, or fixedly attached to outer surface 615 at distal end 618.
  • Reduction ring 620 includes a plurality of exit ports 622 and temporary barb 626 disposed at distal end 628.
  • Annulus reduction assembly 600 functions similarly to annulus reduction assemblies described above. Barb assembly 610 can be axially translated within reduction ring 620 such that barbs 614 will align with, and extend through corresponding exit ports 622 to penetrate the annulus of the target valve.
  • Lock members 616 cooperate, like a ratchet and pawl, with reduction ring distal end 628 or lock 470 to form an adjustable, one-way lock mechanism.
  • Temporary barb 626 may be incorporated to provide stability during the first stages of the implantation procedure.
  • Barb assembly 610 and reduction ring 620 include flexibility notches 612 and 624, respectively, for selectively improving the flexibility and formed shape of the implanted annulus reduction device. Flexibility notches 612 and 624 may be thermoformed or cut by laser, knife, hot wire or by any other means known in the art, and are generally arranged in a linear series along the bodies of barb assembly 610 and reduction ring 620, respectively.
  • flexibility notches 612, 624 When assembled, flexibility notches 612, 624 are positioned in opposite directions in relation to each other such that, during ring formation, flexibility notches 612 are generally oriented towards the outside radius of the annulus reduction ring and flexibility notches 624 are oriented towards the inside radius of the annulus reduction ring. During ring formation, flexibility notches 612 open and flexibility notches 624 close. The amount that notches 612, 524 either open or close depends on the desired size and shape of the final implanted annulus reduction device.
  • Barb assembly 610 and reduction ring 620 may be composed of biocompatible metals, polymers or combinations thereof, examples of which were described above.
  • Barbs 614 may be composed of materials such as nitinol, cobalt-based alloy, stainless steel, or combinations thereof.
  • FIGS. 8-10 illustrate another embodiment of an annulus reduction ring assembly 800 in accordance with the present invention.
  • barbs 810 may be integrally formed with, or fixedly attached to wall 822 of annulus reduction ring 820.
  • reduction ring 820 is laser-cut in such a manner as to create sharp pointed portions in several locations. These sharp pointed portions may then be shaped, and optionally heat-set into barbs 810.
  • Barbs 810 are composed of a biocompatible material such as nitinol, stainless steel, cobalt-based alloy or combinations thereof.
  • FIG. 8 illustrates that each barb 810 is restrained in a delivery position by a restraining device 812.
  • Restraining devices 812 may be disposed along filament 830, which may be as described above for filament 214. Filament 830 is pulled through reduction ring 820 in the direction of arrow A to slip restraining devices 812 off of barbs 810, thus releasing barbs 810 into their pre-shaped forms.
  • FIG. 9 illustrates reduction ring 820 in a straight configuration with barbs 810 in the released position. As described in above embodiments, it will be understood that reduction ring 820 is emplaced within and adjacent to a cardiac valve annulus before anchoring barbs are implanted therein. Referring to FIG.
  • FIG. 11 illustrates another embodiment of an annulus reduction ring assembly 1100 in accordance with the present invention.
  • reduction ring 1120 includes a stop 1122. Stop 1122 may be formed separately from reduction ring 1120 and attached by welding or adhesive or any other means known to those with skill in the art. Alternatively, a portion of reduction ring 1120 may be cut out and bent down into lumen 1124 to form stop 1122.
  • Stop 1122 extends across lumen 1124 a sufficient length to prevent movement of barb body 1112 beyond stop 1122, but stop 122 provides sufficient clearance to allow unrestrained movement of filament 1130 through lumen 1124.
  • Stop 1122 includes a chamfered or rounded end 1126 for preventing damage to elongate member 1130, which may contact stop 1122.
  • FIG. 11 also illustrates an alternative embodiment of a barb wherein tissue-penetrating portion 1114 of barb 1110 is positioned substantially in the center of top surface 1116 of barb body 1112. [00060] In the previously described embodiments of the invention, damage may occur to a barb extending through an exit port in a reduction ring.
  • FIGS. 14-16 illustrate another embodiment of a lock mechanism 1400 that may be used in conjunction with the annulus reduction assemblies described herein.
  • FIG. 14 is a perspective view of lock mechanism 1400 and FIGS. 15 and 16 are longitudinal cross-sectional views of lock mechanism 1400.
  • Lock mechanism 1400 comprises tab 1430 disposed at distal end 1412 of annulus reduction ring 1410.
  • a plurality of keyholes 1420 is disposed along distal end 1442 of filament 1440.
  • Filament distal end 1442 may comprise a flattened section of filament 1440 or a separate component attached thereto.
  • Tab 1430 may be formed integrally with reduction ring 1410 or tab 1430 may have been formed separately and attached to reduction ring 1410 by welding, adhesive or by any other attachment method known in the art.
  • Tab 1430 is biased toward lumen 1416 of reduction ring 1410.
  • Tab 1430 includes cord opening 1432 for receiving unlocking cord 1460 in a threaded manner and tip 1434 for insertion into one of keyholes 1420.
  • Locking mechanism 1400 also includes push tube 1470 and lock support tube 1480.
  • Push tube 1470 and lock support tube 1480 may be composed of an incompressible biocompatible metal, polymer or combination thereof that is sufficiently flexible to traverse the vasculature to the target valve.
  • lock support tube 1480 is advanced so that end 1482 abuts end 1414 of reduction ring 1410. Then, while holding lock support tube 1480 in place, lock engagement cord 1450 is pulled to draw filament 1440 through reduction ring 1410 until tip 1434 engages with a selected keyhole 1420 in filament distal end 1442.
  • Lock mechanism 1400 may be unlocked if desired.
  • reduction ring 1410 is held in place by lock support tube 1480 as described above. Then, unlocking cord 1460 is pulled in the direction indicated by arrow B to disengage tip 1434 from keyhole 1420.
  • unlocking cord 1460 is pulled in the direction indicated by arrow B to disengage tip 1434 from keyhole 1420.
  • the clinician can readjust the annulus reduction ring and re-lock locking mechanism 1400 as needed.
  • push tube 1470 may be advanced in the direction indicated by arrow A to abut filament distal end 1442. While tip 1434 is held disengaged from keyhole 1420, push tube 1470 may be used to translate filament 1440 proximally into reduction ring 1410 until the desired annulus reduction configuration is formed.
  • FIGS. 17-18 illustrate delivery system 1700 for delivering the annulus reduction systems described herein.
  • Delivery system 1700 comprises wireform 1705 having pre-shaped annular portion 1710, proximal portion 1740 and stabilizer portion 1750.
  • Wireform 1705 may be composed of biocompatible metal, polymer or combinations thereof. In one embodiment, wireform 1705 is pre-shaped and sized to fit the anatomy of a particular patient.
  • pre-shaped annular portion 1710 comprises nitinol. In another embodiment, pre-shaped annular portion 1710 comprises a section of tubular braid, either with or without a central monofilament core extending there through. Pre-shaped annular portion 1710 provides a rail or guide for positioning an annulus reduction delivery system or device around and within the annulus of mitral valve 1730.
  • FIG. 18 illustrates wireform 1705 in a straight configuration as it may appear either during manufacture and before annular portion 1710 is shaped, or as wireform 1705 may temporarily appear during delivery to a cardiac valve through a delivery catheter.
  • Wireform stabilizer portion 1750 extends distally from pre- shaped annular portion 1710 and, in one embodiment, extends through mitral valve 1730 and into left ventricle 1715. Stabilizer portion 1750 traverses the left ventricle to rest on or near the apex of the ventricle adjacent papillary muscles 1735 to provide stability for wireform annular portion 1710 during placement of an annulus reduction system. Stabilizer portion 1750 may comprise a material that is relatively soft at distal tip 1760 forming a pigtail or spiral shape as is known in the art. In another embodiment, stabilizing portion 1750 extends from annular portion 1710 in a superior direction to rest against an upper portion of the left atrium 1725 to provide stability.
  • wireform 1705 does not include stabilizing portion 1750.
  • Delivery system 1700 provides a pathway to and around the mitral valve annulus for delivering and positioning an annulus reduction assembly for implantation.
  • delivery system 1700 is delivered to left atrium 1725 through the patient's vasculature in the same or similar manner as described above for delivery of an annulus reduction device.
  • delivery system 1700 is preceded to the treatment site by a puncture catheter and/or a dilator catheter.
  • Previously described elongate element 132 or delivery catheter 252 may be employed to deliver wireform 1705 to the target cardiac valve.
  • Delivery catheter 1800 for deliveri ng wireform 1705 having a stiff heat-set pre-shaped annular portion 1710.
  • Delivery catheter 1800 includes proximal section 1810, restraining section 1820 and soft distal tip 1830.
  • Delivery catheter 1800 comprises a flexible, biocompatible polymeric material such as polyurethane, polyethylene, nylon, or polytetrafluroethylene (PTFE).
  • restraining section 1820 has sufficient stiffening capabilities to maintain pre-shaped annular portion 1710 in a straightened delivery configuration.
  • a braided metallic or polymeric material is embedded in the wall of restraining section 1820.
  • metallic or polymeric rods are embedded in the wall of restraining section 1820.
  • wireform 1705 is inserted into delivery catheter 1800. Delivery catheter 1800 is then advanced to the target valve as described above. In one embodiment, distal end 1835 is positioned within left atrium 1725 and wireform 1705 is pushed out of delivery catheter 180O to form delivery system 1700 as seen in FIG. 17. In another embodiment, distal end 1835 is advanced through the mitral valve and positioned adjacent papillary muscle 1735. Delivery catheter 1800 is then retracted while wireform 1705 is held stationary. As delivery catheter 1800 is retracted, delivery system 1700 forms as seen in FIG. 17. [00069] Once delivery system 1700 is placed as seen in FIG. 17, delivery system 1700 may be used to guide an annulus reduction delivery catheter to the mitral valve annulus.
  • FIGS. 20 and 21 illustrate two embodiments of annulus reduction ring delivery catheters that may be used with delivery system 1700. [00070] FIG. 20 illustrates annulus reduction ring delivery catheter
  • Annulus reduction ring delivery catheter 1800 comprises a flexible, biocompatible polymeric material such as polyurethane, polyethylene, nylon, or polytetrafluroethylene (PTFE).
  • Guide section 1930 slides over delivery system 1700 for delivery to the mitral valve annulus 1730.
  • Distal section 1920 comprises a flexible material suitable for traversing rigid pre-shaped annular portion 1710 of delivery system 1700.
  • FIG. 21 illustrates annulus reduction ring delivery catheter 2000 comprising proximal section 2010, distal section 2020 and guide section 2030 similar to that of annulus reduction ring delivery catheter 1900.
  • guide section 2030 comprises a plurality of spaced apart segments for sliding over wireform 1705.
  • Delivery system 2100 comprises outer tube 2110, inner core 2160 and lock 2150.
  • Inner core 2160 includes middle section 2120 and tapered distal portion 2130.
  • Delivery system 2100 further comprises a coil disposed about middle section 2120 and tapered distal portion 2130 for providing flexibility in bending.
  • the shape of delivery system 2100 is similar to that of delivery system 1700 illustrated in FIG. 17.
  • delivery system 2100 does not include a stabilizing section.
  • distal portion 2130 forms the annular ring corresponding to pre-shaped annular portion 1710 by mechanical actuation of inner core 2160.
  • Inner core 2160 is attached to the distal end of the coil by soldering, welding, adhesive or other means known in the art.
  • outer tube 2110 is held stationary while inner core 2160 is pulled in a proximal direction.
  • a ring shape forms (not shown) comprising middle section 2120 and tapered distal portion 2130.
  • This actuation mechanism is similar to that of a steerable catheter, as such devices are known in the art.
  • the formed ring can be locked in place using lock 2150.
  • Lock 2150 may comprise a crimp or other type of friction lock.
  • delivery system 2100 may be used to guide annulus reduction delivery catheter 1900, 2000 to the mitral valve. [00072] FIG.
  • FIG. 23 shows a flow chart for a method 2200 of using cardiac valve annulus reduction system 100 in accordance with the present invention.
  • An exemplary embodiment provides a method 2200 for treating mitral valve regurgitation. Method 2200 will be described with particular reference to the embodiment illustrated in FIG. 3.
  • the method begins by delivering annulus reduction assembly 200 adjacent the mitral valve annulus (Block 2210) using, for example, delivery catheter 252.
  • the annulus reduction assembly can be delivered percutaneously or surgically. Once the delivery catheter is positioned adjacent the mitral valve annulus, annulus reduction assembly 200 is deployed around and within the valve annulus in the ring shape and position intended for implantation (Block 2220).
  • annulus reduction assembly 200 To deploy annulus reduction assembly 200, the clinician holds ring holding tube 254 and retracts delivery catheter 252, and reshaping cord 240 loops cord ring 242 around toward lock 234 to form the intended ring shape.
  • annulus reduction assembly 200 can be advanced through delivery catheter 252 in order to deploy the device.
  • annulus reduction assembly 200 is delivered to, and positioned in a ring shape within the mitral valve annulus using delivery system 1700 illustrated in FIGS. 17-19.
  • Annulus reduction assembly 200 includes barb assembly
  • barb penetrating members 218 are deployed through exit ports 224 to penetrate the valve annulus (Block 2230).
  • Barb penetrating members 218 are deployed by holding distal end 270 of ring holding tube 254 in contact with proximal end 272 of reduction ring 220 and pulling on actuator cord 258. Pulling on actuator cord 258 translates filament 214 in a proximal direction which allows barb penetrating portions 218 to advance through exit ports 224 and enter the valve annulus to securely anchor within the tissue of the annulus.
  • Ring holding tube 254 may be removed following deployment of barb penetrating portions 218.
  • annulus reduction assembly 200 Prior to deployment of barb penetrating members 218, temporary barb 222 is inserted into the valve annulus to provide a stable position for annulus reduction assembly 200 while initially forming the ring shape and/or during barb deployment.
  • the clinician reforms the ring shape of annulus reduction assembly 200 (Block 2240).
  • the ring is cinched, or reformed by holding the position of lock 234 with lock holding tube 256 while pulling reshaping cord 240 in a proximal direction.
  • the reformation of annulus reduction assembly 200 reduces at least one transverse dimension of the ring shape and reshapes the valve annulus as a result of forces applied to the valve annulus tissue by implanted barb penetrating members 218.
  • annulus reduction assembly 200 causes a reduction in the valve annulus, thus providing for more complete closure of the valve leaflets during systole.
  • Annulus reduction assembly 200 is locked in the desired configuration by engaging one of key members 232 with lock 234 (Block 2250). As key members 232 pass through lock 234, as described and illustrated in FIGS. 12-13, key members 232 are prevented from backward movement by deflectable tabs 238. This engagement locks the annulus reduction assembly 200 in the annulus reduction configuration. Following the locking of annulus reduction assembly 200, reshaping cord 240 and lock holding tube 256 are removed.
  • Reshaping cord 240 may be removed by releasing a first end of the looped cord and pulling on the second end until the first end exits the patient.

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Abstract

La présente invention concerne, d'une part un dispositif et un système de réduction de l'annulus, à base de cathéter, pour réparer les valvules cardiaques, et d'autre part un procédé d'utilisation correspondant. Ce système, qui est disponible pour traiter la régurgitation de la valvule mitrale, comprend un cathéter, un anneau réducteur porté à l'intérieur du cathéter et comprenant une pluralité d'orifices de sortie dans l'une de ses parois latérales, un filament étant reçu dans l'anneau réducteur. Le filament comporte une pluralité de barbules à déploiement radial correspondant aux orifices de la paroi latérale. On déploie contre l'annulus de la valvule mitrale l'anneau réducteur portant le filament, puis le filament subit une translation par rapport à l'anneau réducteur, ce qui fait que, d'une part les barbules se déploient au travers des orifices de sortie, pénétrant dans l'annulus, et d'autre part on continue à faire glisser l'anneau réducteur aux barbules déployées de façon à modifier la forme de l'annulus.
PCT/US2004/037867 2003-11-12 2004-11-12 Systeme de reduction de l'annulus des valvules cardiaques Ceased WO2005046488A2 (fr)

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EP04810885A EP1689329A2 (fr) 2003-11-12 2004-11-12 Systeme de reduction de l'annulus des valvules cardiaques
US10/531,819 US7655040B2 (en) 2003-11-12 2004-11-12 Cardiac valve annulus reduction system

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WO2005046488A3 (fr) 2005-11-24
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US20070051377A1 (en) 2007-03-08
US7655040B2 (en) 2010-02-02

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